Amgen Announces Positive Phase 2 Results In A Rare Form Of Blood Cancer

Amgen (AMGN) reported after the bell today that it has obtained positive phase 2 results in treating patients with Relapsed/Refractory Philadelphia chromosome-positive B-cell precursor Acute Lymphoblastic Leukemia -- PH+ ALL. This phase 2 trial used blinatumomab -- known as Blincyto -- to treat patients with this rare form of blood cancer.  Blincyto was previously approved by the FDA for treating a different form of ALL (Philadelpha chromosome-negative).

This trial was run as a single-arm monotherapy in which all the patients were given treatment with Blincyto. In addition the drug was being evaluated for efficacy in terms of survival while the patient was on the drug, and for the safety of the drug. The trial was split into three different phases: 

1. An initial treatment phase which consisted of two treatment cycles
2. An additional three cycles for those patients who met the criteria to receive this phase
3. A follow up period of 30 days after last treatment cycle

The results showed that a clinically meaningful group of patients who took Blincyto as a monotherapy were able to achieve complete remission or complete remission with partial hematological recovery within at least the first two initial treatment cycles of therapy. The drug was safe and well tolerated for the most part but there were some serious adverse events in some patients.

The detailed results will be sent for publication in a medical journal. In addition the detailed results will be submitted and displayed at a future medical conference.